FDA INCREASES PRICE OF DRUG BY 10,000%

If you want an example of how government meddling in health care raises rather than lowers costs, you need look no further than the FDA’s idiotic policy on a venerable gout medication called colchicine:

Gout sufferers can thank the FDA for the 10,000% increase in the price of an old treatment. An old drug used to treat gout (colchicine) used to cost mere pennies per tablet but now a newly approved version is $5 per pill.

How did the FDA work this miracle? It granted a monopoly to a pharmaceutical manufacturer called URL Pharma, Inc.

The FDA recently gave the maker of [colchicine] exclusive rights to market it for three years. The period of exclusivity was in return for commissioning several studies showing this drug (that has been used for decades) was in fact, safe and effective.

So, like all monopolies (which, by definition, have no competitors who might offer lower prices) URL was able to raise the price with impunity. Why is the FDA pursuing a policy that so clearly works against the consumer? Control, of course:

Many drugs already in existence when the FDA gained control over approval for prescription drugs were allowed to continue to be sold [like aspirin]. The FDA has recently begun trying to rein in some of the old drugs that predate the FDA approval process.

So, the FDA is granting monopolies that hurt the consumer simply because it, like all government bureaucracies, wants to expand its power. It wants to wrap its tentacles around anything it does not already control.

Welcome to the world of government-run health care.

Comments 11

Marc Brown wrote:

I agree – this is not good. But how would you find out whether the drug is effective or not?

No – colchicine is a highly toxic drug and the key clinical trial now done has established lower effective dosage and will eliminate side-effects for many. Unfortunately, huge numbers of so-called treatments are given with little evidence of their effectiveness and toxicity, dangers of interactions with other drugs, and with poor manufacturing standards.

I’m sure you’re not really arguing that we abandon randomised controlled trials. In this case, the company has a license only for 3 years.

Similar safety and efficacy studies were done on digoxin a few years ago, funded largely by NIH grants (by my recollection) and no single pharma was granted exclusivity. So now, in the name of cost control, the cost of determining safety and effectiveness has been heaped upon those who must pay for the medication and may be the most likely to be unable to afford it.

This seems contradictory to the notions of making healthcare affordable for all and reigning in costs – central tenets of the Obama administrations healthcare policy. Particularly when this could have been funded in such a way to preserve safety for all patients without granting a huge gift to URL Pharma. Where is the outrage from the left about this?

It is possible that this deal predates the Obama administration, but one should be no less outraged by it, as well as the silence from the Whitehouse on the matter.

The consequences may be more than simply the financial burden of paying increased costs. Patients may opt for cheaper alternatives, like indomethacin, which while effective for gout, has significant renal and gastrointestinal risks. It is certainly possible that this odd FDA action might lead to complications in some patients whose gout has been manged safely and effectively for decades. The monopoly aspect of this seems unnecessary and unjust.

Hey – I said I agree this is not ideal (but the company was the only one that offered to do the trial). But the key question is whether we should conduct clinical trials to fill in evidence gaps. The answer is obviously yes – especially in this case where the substance is highly toxic and has in fact caused several hundred deaths. The ideal would be for the government to fund the trials but they are expensive.

“But the key question is whether we should conduct clinical trials to fill in evidence gaps.”

I agree. Without RCTs, we might as well go back to the days of the traveling snake oil salesmen.

As to the topic, $5 a pill might as well be Tijuana pricing when compared to what Jazz Pharmaceuticals gets for Xyrem. Same story. They ran clinical trials on an older and commonly-used (in other countries) pharmaceutical agent. Now they’re getting something like 2 grand a month to produce this simple molecule that they didn’t even have incur any R&D cost to develop.

But the key question is whether we should conduct clinical trials to fill in evidence gaps.

Nope. That’s merely the straw man that Marc intoduced to avoid dealing with the actual “key question.” That question is as follows:

Should a federal bureaucracy use clinical trials as a pretext for an arbitrary power grab that results in a hidden tax for the consumer and adds no value to the health care system?

A secondary question is this: Why was this particular company chosen for corporate welfare? I imagine the answer to that query involves which political party has received campaign donations from the executives and employees of URL Phrama, Inc.

How do you know that the company was the only one that “offered” to do the trial? Was there an RFP? Did the NIH make a grant available? Were all of the university researchers so flush with grants that none were interested? Digoxin was studied, and no manufacturer needed to be so coerced to do so.

No. The government decided it was easier to “tax” people with gout to pay for the study. I am sure it was. But I fail to see how doing something expensive is a deterrent to government (see ObamaCare).

I agree with z9z99 – I anticipate all the phone calls asking for cheaper alternatives such as indomethacin. Unfortunately, such treatment is inappropriate for chronic use, unlike colchicine, and has a much higher adverse event rate than does colchicine.

I think you don’t understand this – I don’t think it’s as contentious as you think. The problem was that all the colchicine drugs were unapproved – they weren’t approved generics. For such a highly toxic substance this is surely not acceptable. There will be competition for several indications of approved versions but it is up to the companies to come forward as well. With modern pharmacodynamics and pharmacokinetics it is possible to discover much more about drug actions and safe dosing, and drug-drug interactions must also be studied especially for people taking a cocktail of drugs. This is not possible without clinical trials and studies.